Siemens Healthineers (ETR: SHL) today announced that it’s secured an FDA emergency use authorization for its SARS-CoV-2 IgG (COV2G) antibody test, which the company touts as the first authorized with semi-quantitative detection.
The COV2G test not only provides positive or negative result for IgG antibodies but also reports a numerical result expressed as index value — helping clinicians to gauge the level of IgG antibodies in a patient’s blood sample. The idea is that the test will help clinicians better understand how people’s immune response changes over time after exposure to the virus that causes COVID-19.
The test has also attained the CE Mark in the European Union and is now broadly available globally. The test, according to Siemens, has b sensitivity and specificity that is greater than 99%.
“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” Deepak Nath, president of Laboratory Diagnostics for Siemens Healthineers, said in a news release.
This is the fifth Siemens Healthineers antibody test for COVID-19 to receive an FDA EU since the pandemic began.
“Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19,” Nath said.